Bayer announced positive topline results of the pivotal Phase III QUANTI studies evaluating the efficacy and safety of gadoquatrane, an investigational gadolinium-based contrast agent (GBCA) for use in magnetic resonance imaging (MRI). All QUANTI studies investigated gadoquatrane at a gadolinium dose of 0.04 mmol Gd/kg body weight which represents a gadolinium dose reduction of 60% compared to the macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight. Gadoquatrane successfully met the primary and main secondary endpoints of all QUANTI studies.
The QUANTI clinical development program encompassed two multinational Phase III studies, QUANTI CNS (central nervous system) and QUANTI OBR (other body regions) in adult patients, as well as QUANTI Pediatric, a study investigating pharmacokinetics and safety in pediatric patients from birth to In QUANTI CNS and QUANTI OBR, researchers investigated the ability to visualize and detect known or suspected disease on MRI scans using gadoquatrane (0.04 mmol Gd/kg body weight) compared to scans without contrast injection and compared to scans using macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight. Topline results show that gadoquatrane met the primary and main secondary efficacy endpoints of the studies assessing visualization parameters and lesion detection. Results of QUANTI Pediatric demonstrated that the pharmacokinetic behavior of gadoquatrane in children is similar to that in adults.
The observed safety profile in adults as well as pediatric patients from birth to < 18 years of age in the QUANTI studies was generally consistent with previous data on gadoquatrane and other macrocyclic GBCAs. No new safety signals were observed. Bayer plans to submit a comprehensive data package which will include the QUANTI study results to health authorities worldwide to secure marketing authorization.
The QUANTI clinical development program consisted of two large multicenter, randomized, prospective double-blind, cross-over Phase III studies ? QUANTI CNS and QUANTI OBR ? as well as the QUANTI Pediatric study.
In total, 808 patients in 15 countries were included in the program. QUANTI CNS evaluated the efficacy and safety of gadoquatrane in adults with known or highly suspected pathologies of the central nervous system undergoing a contrast-enhanced MRI. In common CNS disorders, such as brain tumors, brain metastasis and multiple sclerosis, MRI plays a key role in diagnosis and treatment decisions.
QUANTI OBR investigated the safety and efficacy of gadoquatrane in contrast-enhanced MRI of all other body regions, including head and neck, thorax including the breast and the heart, abdomen, pelvis, and extremities, as well as blood vessels with magnetic resonance angiography (MRA). QUANTI Pediatric assessed the pharmacokinetics and safety of gadoquatrane in children from birth to The design and dosing of the Phase III clinical development program was based on the positive data from the Phase II study evaluating efficacy and safety of gadoquatrane at a dose of 0.04 mmol Gd/kg body weight. The Phase II study was a multicenter, single-blind, adaptive dose-finding study of single intravenous injections of gadoquatrane with corresponding blinded review in adult patients with known or highly suspected CNS lesions referred for contrast-enhanced MRI.